This application claims the benefit of U.S. Provisional Patent Application Ser. No. 61/754,226, entitled USE OF LOCAL ANESTHESIA AND ELECTRICAL STIMULATION IN PERIPHERAL WOUND TREATMENT, filed on Jan. 18, 2013, the entire content of which is hereby incorporated by reference.
The present disclosure pertains to methods for treating wounds, improving wound healing, treating peripheral neuropathic pain, and regeneration of sensation caused by peripheral nerve damage, by administering a combination of local and deep nerve analgesia and electrical stimulation.
Slow healing wounds and chronic foot ulcers are a common problem in the United States and can dramatically affect the quality of life of patients who present with this. Patients with Diabetes and peripheral arterial disease are at risk for developing serious health problems that affect the eyes, kidney, skin, feet and heart. Foot ulcerations are one of the most common complications in patients with these conditions. The development of foot ulcers typically develop from diabetic neuropathy and large vessel disease such as patients who suffer from peripheral arterial disease. Most commonly diabetic foot ulcers (“DFUs”) are caused by peripheral neuropathy complicated by deformity, callus, and trauma. Vascular insufficiency, infection, and failure to implement effective treatment of DFUs are linked to secondary medical complications, such as osteomyelitis and amputation. Approximately 15% of DFUs result in lower-extremity amputation. More than 85% of lower-extremity amputations in patients with diabetes occur in people who have had an antecedent foot ulcer.
The 5-year mortality rate for patients with neuropathic and ischemic DFUs is 45% and 55%, respectively. General healing rates for neuropathic DFUs have been reported in the literature. The meta-analysis of 10 control groups from clinical trials, using good standard wound care (including debridement and off-loading, and either saline moistened gauze or placebo gel and gauze) demonstrated that the weighted mean rates of neuropathic ulcer healing were 24.2% (95% confidence interval [CI] 19.5-28.8%) over 12-weeks and 30.9% (95% CI 26.6-35.1%) over 20 weeks. These data provide clinicians with a realistic benchmark for the rate of healing of neuropathic ulcers over 20 weeks.